James Foster1:53
Thank you and good morning. As Todd mentioned, I'm pleased to be joined today by Birgit Gershik, who will become our next CEO when I retire in May, as well as our interim CFO, Mike Nell. Birgit will provide an overview of our 2026 guidance and the key drivers behind our outlook. But before I hand the call over to her, I will provide details on our fourth quarter and full year 2025 financial results, as well as an update on our latest developments and market trends. We were pleased that our 2025 financial results were at the upper ends of the revenue and non-GAAP earnings per share ranges that we provided in November. Beyond our financial results, the fourth quarter capped a year that was marked by the stabilization of the biopharma demand environment, including substantial improvements in DSA net bookings, particularly during the first and fourth quarters. We also advanced several strategic initiatives that will enable the company to better capitalize on future growth opportunities and renewed our focus on scientific innovation that will reinforce our position as the leader in pre-clinical drug development.
At different points during 2025, demand from both global biopharmaceutical clients and small and midsize biotechnology clients showed signs of improvement. Many of our global biopharma clients progressed through their restructuring and pipeline reprioritization activities and after holding back spending in 2024, moved their programs forward with more urgency when new budgets were released in early 2025, which led to strong DSA bookings at the start of last year. The biotech funding environment slowed in the first half of 2025 and we subsequently experienced softer demand trends from our small and midsize biotech clients during the summer months. However, with a reinvigorated funding environment in the second half of the year, including a record level of $28 billion in the fourth quarter, biotech clients were the primary driver behind a steady sequential increase in the DSA net book-to-bill in each month during the second half of the year. As we disclosed at an investor conference last month, the DSA net book-to-bill improved to 1.1 times in the fourth quarter. Taking these factors into account, we are cautiously optimistic that the favorable DSA demand trends will continue in 2026 and result in a return to organic revenue growth in the second half of the year for both the DSA segment and the overall company.
We have also made substantial progress on the strategic actions that we outlined in November to unlock long-term shareholder value, including strengthening and refining our portfolio, driving greater efficiency, and maintaining a balanced yet disciplined approach to capital deployment. To strengthen our portfolio, in January, we announced the planned acquisitions of the assets of KF Cambodia and Pathoquest. Both of these acquisitions are squarely aligned with our core competencies and are the result of lengthy successful partnerships. KF, the acquisition of which has already closed, has been our longtime NHP supplier in Cambodia and will further strengthen and secure our DSA supply chain. We expect it will generate meaningful operating margin improvement starting later this year through significant cost savings on NHP sourcing between KF and Novabiosciences. We expect to own and internally source most of our future annual NHP supply requirements for the DSA segment. We continue to advance our NAMs capabilities with the planned acquisition of Pathoquest, which is expected to close within the next month. The company has been a partner of our biologics testing business since 2016 and provides an in vitro approach to manufacturing quality control testing for biologics. The KF and Pathoquest acquisitions are excellent examples of capital deployment in core areas that will enhance our financial profile and advance our scientific capabilities. As we endeavor to capture greater share of wallet from our clients, we will continue to evaluate additional M&A including in the areas of bioanalysis and geographic expansion in order to support our clients as they seek to drive greater efficiency and success in their drug development programs.
We are also focused on continuing to build our NAMs portfolio or new approach methodologies in areas that are most relevant to clients and their scientific needs. We believe we have already established a solid foundation of NAMs capabilities, including our Retrogenix cell microarray platform for off-target screening and toxicity, our development of virtual control groups for safety assessment studies that utilize machine learning and other techniques, and most recently Pathoquest's innovative next-gen sequencing platform. We are excited about current and future applications for NAMs and related innovations including AI and we view these as enabling technologies to support the work that we do and is complementary to it. NAMs including AI has promise but it still has challenges with data availability and proof of concept. So it will be a gradual longer-term evolution led by science and the validation of new capabilities over time, particularly in a regulated safety assessment environment where patient safety is paramount. Since we began to discuss NAMs in more detail last spring, there have not been any significant technological changes in drug development and we have not experienced any notable changes in client behavior other than more frequent conversations about NAMs.
We also continue to make progress on our plan to divest non-core assets totaling approximately 7% of 2025 annual revenue. These processes and negotiations with potential buyers are ongoing and we continue to expect the planned divestitures will be completed by the middle of 2026. Assuming all transactions are completed, the expected non-GAAP earnings per share accretion of 30 cents on an annualized basis from the planned divestitures will be less for the partial year 2026 or closer to 10 cents per share because of expected improvements in the operating performance of these businesses throughout the year. Now, I will recap our fourth quarter and full year consolidated performance. We reported revenue of $994.2 million in the fourth quarter of 2025, a 2.6% decline on an organic basis from the previous year with revenue declines in all three business segments. For the full year, we reported revenue of $4.02 billion with an organic revenue decrease of 1.6% driven primarily by lower revenue in the DSA and manufacturing segments. By client segments, sales to both the global biopharma and small and midsize biotech client segments declined modestly for the full year. In the fourth quarter, sales to global biopharma clients rebounded meaningfully versus the prior year as these clients got back to work after pulling back on spending at the end of 2024.
Sales to small and midsize biotech clients decreased modestly in the fourth quarter, largely reflecting softer DSA bookings during the summer months. As a reminder, there's a natural lag between when DSA studies are booked and when they start and begin to generate revenue. Therefore, it will take one to two quarters to see the benefit of the stronger fourth quarter bookings. The operating margin decreased 180 basis points year-over-year to 18.1% in the fourth quarter, principally driven by three anticipated factors: lower revenue, higher staffing and NHP sourcing costs in the DSA segment, and the timing of NHP shipments in the RMS segment. For the full year, the operating margin declined by just 10 basis points to 19.8% as the cost savings from restructuring and efficiency initiatives helped to protect the operating margin, which has been our stated goal. Earnings per share were $2.39 in the fourth quarter, a decrease of 10.2% from $2.66 in the fourth quarter 2024. In addition to the lower operating margin, the tax rate was also a meaningful year-over-year headwind in the fourth quarter. For 2025, earnings per share were nearly flat at $10.28 compared to $10.32 in 2024 as lower revenue was largely offset by the benefit of the cost-saving initiative. Below the line items largely netted out with a higher tax rate in 2025, primarily offset by lower interest expense and a lower share count from stock repurchases earlier in the year.
I will now provide additional details on the segment performance. DSA revenue in the fourth quarter was $591.6 million, a decrease of 3.3% on an organic basis. The decline reflected lower study volume, particularly for discovery services, while DSA pricing and mix were relatively stable. For the year, DSA revenue decreased 2.6% on an organic basis. As a result of client demand, we experienced a meaningful increase in revenue from NHP studies, resulting in an increase in the number of NHPs used in these studies in 2025, for which additional information can be found in the appendix of our slide presentation. These trends reflect our clients' continued reliance on traditional in vivo methods to help ensure drug safety. Even as we and our broader industry continue to evaluate applicable uses for NAMs and further expand our capabilities, we experienced a higher number of NHP study starts in the fourth quarter and this trend is expected to continue into the first quarter. As we mentioned in November, the higher than expected NHP study demand led to increased NHP sourcing costs in the fourth quarter and will again in the first quarter. However, due in part to the acquisition of KF, we expect NHP sourcing costs will normalize over the course of the year.
As we previously disclosed, DSA demand KPIs improved in the fourth quarter, led by net booked-to-bill of 1.12 times on net bookings of $665 million, representing a meaningful increase from 0.82 times in the third quarter. The sequential improvement was principally driven by small and mid-sized biotech clients. While global biopharma clients also contributed with both sequential and year-over-year bookings increases. Proposal value continued to be stable to improved in the fourth quarter as it was for most of the year and cancellations remained at lower levels consistent with the third quarter. At year end, the DSA backlog modestly improved to $1.86 billion from $1.80 billion at the end of the third quarter. Collectively, these trends lead us to believe that the favorable DSA demand environment will continue in 2026. However, it is important to note that this improvement may not be linear as demonstrated in 2025 and also that fourth quarter and more recent bookings activity will not more fully benefit DSA revenue growth until the second quarter due to the normal lag between booking and study start.
The DSA operating margin was 20.1% in the fourth quarter, a 460 basis point decrease from the fourth quarter of 2024. And it was 24.2% for the full year, representing a 150 basis point decline year-over-year. Both the fourth quarter and full year declines were driven by lower revenue and higher costs related to increased NHP sourcing costs and study starts in the fourth quarter as well as higher staffing costs as we had previously anticipated.
RMS revenue in the fourth quarter was $263 million, a decrease of 0.9% on an organic basis. For the year, RMS revenue increased 1.2% on an organic basis. The fourth quarter decline was primarily driven by two factors: lower NHP revenue and lower sales volume from small models in North America. NHP revenue was impacted by the timing of certain shipments, which as previously noted had been accelerated to earlier in the year. In the small research models business, lower sales volume in North America reflected that in-house research activity by our large pharma and midsize biotech clients has not fully recovered. Revenue from academic and government accounts remained very stable, but the growth rate has slowed compared to prior year due in part to the government uncertainty including with NIH budgets. Small model pricing in North America and Europe continue to be a positive contributor to RMS revenue and in Europe is offsetting the expected volume declines. In China, small model unit volume continue to grow nicely. Revenue from research model services increased in the fourth quarter, but occupancy for our Cradle sites remain pressured by the early stage biotech market environment. The RMS operating margin decreased by 90 basis points year-over-year to 21.9% in the fourth quarter, but increased by 110 basis points to 24.8% for the full year. The fourth quarter margin was primarily impacted by lower revenue for small models in North America and an unfavorable revenue mix due to the timing of NHP shipments. For the year, the operating margin improvement was primarily due to a favorable mix related to higher NHP revenue as well as cost savings related to our restructuring initiatives.
Manufacturing solutions revenue was $196.4 million for the fourth quarter, a decrease of 2.1% on an organic basis, and full year revenue declined 1.6% organically. The lower fourth quarter and full year growth rates were primarily driven by lower CDMO revenue, principally the result of the loss of one commercial cell therapy client whose revenue declined by nearly $25 million in 2025. The microbial solutions had a strong year with growth across all three testing platforms, Endosafe, Celsis, and Accugenix. However, year-end client ordering patterns were not quite as robust as last year, which caused the fourth quarter growth rate to slow. We were pleased to see the performance of the biologics testing business modestly improve and return to growth in the fourth quarter after a year that was impacted by lower sample volumes from several large clients due to project delays or regulatory challenges. The manufacturing segment's operating margin increased by 340 basis points to 32.1% in the fourth quarter and by 140 basis points to 28.8% for the full year. We were pleased that the segment's operating margin continued to improve and move closer to the 30% level in 2025, driven principally by a solid performance from the microbial solutions business, as well as restructuring actions to generate incremental cost savings, including in the CDMO business.
Before I hand the call over to Birgit to discuss our 2026 guidance, I'd like to take a moment to reflect on my long and fulfilling career at Charles River. As many of you know, in January I announced my planned retirement, effective at the conclusion of our annual meeting of shareholders on May 5th, but I am pleased to remain on our board. Leading the extraordinary team at Charles River as CEO for more than 30 years has been a profound experience and one of the greatest privileges of my life. Together, we built an industry leader with a culture shaped by our remarkable people, a strong and supportive workplace, and world-class science. All of which has enabled us to deliver meaningful outcomes for our clients and patients who rely on us. While I'm proud of our accomplishments from taking the company public on the New York Stock Exchange to transforming Charles River into a global leader in preclinical drug development services and then becoming a respected member of the S&P 500, I am most proud and appreciative of the relationships that I have built over the last five decades with my colleagues, our clients, and all of you, our shareholders and analysts. I sincerely thank you. We have made tremendous progress over the last 12 months, ranging from NAMs and NHP supply to the biopharma demand environment and our strategic review, making this the right time to transition the company into its next chapter. I'm delighted that Birgit Gershik will become our next CEO and it will be in her capable hands to drive forward Charles River's strategic direction, future growth, and operational excellence for many years to come. Birgit has played an instrumental role as COO for nearly five years, leading our global businesses, guiding our digital evolution, and most recently driving our strategic vision. I have worked closely with Birgit for many years and have the utmost confidence in her leadership abilities, and I will continue to work closely with her in the coming months to ensure a seamless transition.
As I sign off on my final earnings call, I'd like to thank our employees profoundly for their exceptional work and commitment. It is their dedication to exquisite science and exceptional client service that has distinguished us as the preeminent provider of pre-clinical services. And always I thank our clients and shareholders for their support over the years. Now I will introduce our next CEO, Birgit Gershik, who will provide details on our 2026 financial guidance.